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YOUR PAREXEL
CARDIOVASCULAR
TEAM
MEET YOUR TEAM OF
CARDIOVASCULAR EXPERTS
Medical Imaging – Cardiovascular Expertise
1
Peter Gardiner, M.B., Ch.B., M.R.C.P., F.F.P.M., Scientific Advisor 2
Henri Francois Cuénoud, M.D., Scientific Advisor4
Richard Jacobs, M.D., M.H.A., Senior Vice President, Medical Affairs5
Edwin Palmer, M.D., Scientific Advisor6
Peggy Harrigan, Medical Research Scientist8
MEDICAL IMAGING:
CARDIOVASCULAR EXPERTISE
As a leading imaging provider for clinical trials,
PAREXEL Informatics has a dedicated cardiovascular leadership team with more than 35 years
of relevant industry experience. These experts
offer multiple solutions to standardize cardiovascular safety and imaging endpoint assessments.
With extensive experience accumulated from supporting over 127 cardiovascular imaging studies
and more than 164,045 timepoints in echo, multi
gated acquisition scan (MUGA), computerized
tomography (CT), and magnetic resonance imaging (MRI). Our global organization is able to adjust
and scale imaging services to meet your needs.
PAREXEL Informatics has best-in-class cardiac
imaging analysis and reporting software;
DigiView,™ Invia Corridor 4DM, and others as needed, coupled and integrated with core PAREXEL
technologies. We offer the flexibility you should
expect from your imaging partner for early phase,
adaptive, and exploratory imaging studies. We
have the know-how to implement large, latephase submission trials effectively and efficiently
with rigor, have completed FDA inspections
without any findings, and successfully run
multiple cardiovas­cular studies that have led to
regulatory approvals.
PAREXEL Informatics Worldwide Clinical Trial Experience in Cardiovascular Imaging studies (past 5 years)
Transfusional Hemosiderosis 1%
Thrombosis (Non-DVT) 4%
Tachycardia (Paroxysmal Atrioventricular) 1%
Stroke 1%
Periperhal Vascular Disease 1%
Periperhal Arterial Occlusion 1%
Obesity (body composition) 7%
Myocardial Perfusion Abnormalities (Contrast Agent) 1%
Myocardial Infarction 2%
Myelodysplastic Syndrome
(Transfusional Iron
Overload) 1%
Other 1%
ACS 1%
Allergy/Immunology 1%
Arterial Disease 3%
Artherosclerosis 3%
Cancer 30%
Multiple Sclerosis 4%
Ischemia 4%
Idiopathic Pulmonary
Fibrosis 2%
Hypertension 1%
Hypereosinophilia
Syndrome 1%
Heart Failure 2%
Fabry Disease 1%
Erectile Dysfunction 1%
DVT (Deep Vein Thrombosis) 9%
Cardiac Safety 3%
Carotid Stent 2%
Contrast Agent 9%
Coronary Lesions 1%
Diabetes 1%
The specific strengths of our cardiovascular experts include:
•Full trial support from consulting through
project execution and regulatory submission
• Intelligent analysis form design to increase
data quality
• Application of best practices spread across
all cardiac studies
• Single-vendor solution for all cardiovascular
imaging modalities, including oncology trials
with cardiovas­cular safety components
• Cost savings by reducing re-reads and
increasing data integrity through independent
reviewer accuracy and reproducibility
• Scalability to tailor cardiovas­cular imaging
solutions to meet individual study requirements
• Program approach to decrease startup time and
costs while increasing team efficiency
Development Area:
MEDICAL IMAGING
Lead Therapeutic Area(s):
CARDIOVASCULAR
Geographic Responsibility:
GLOBAL
Peter Gardiner, M.B., Ch.B., M.R.C.P., F.F.P.M.
Scientific Advisor
Peter is a valued part of the PAREXEL
Informatics cardiovascular group. He has
served as PAREXEL medical owner on over
30 studies, ranging from cardiac safety
assessment in breast cancer trials to the
evaluation of therapies for peripheral vascular
stenosis, including 4 which have led to
successful FDA submissions and approvals.
Peter is the former vice president, medical
affairs and senior medical officer for BG
Medicine, a life sciences company focused on
the discovery, development, and commercialization of novel, molecular diagnostics based
on biomarkers in cardiovascular medicine. He
is also president of Gardiner Consulting, LLC,
an independent consultancy providing medical,
scientific, and regulatory services to the
pharmaceutical, biotechnology, and medical
device industries and the former vice president,
medical sciences for Bristol-Myers Squibb
Medical Imaging.
Peter has been a Scientific Advisor to
PAREXEL’s cardiovascular imaging team for
6 years and continues to provide sponsor
consultation for protocol development and study
design, novel imaging modalities, and internal
consultation on software acquisitions.
Work Experience
As a seasoned pharmaceutical physician
with 25 years of global industry experience,
Peter has a proven track record of success
in clinical research, medical affairs, and
regulatory affairs. His diverse experience
ranges from large pharmaceutical companies
to small biotechnology organizations and
encompasses drug and device development and
support, predominantly in the cardiovascular
therapeutic, diagnostic, and imaging areas.
Peter’s achievements include U.S. and
European approval and launch of a unique
drug/device combination pharmacological
stress product; clinical, medical, and regulatory
support to the market-leading cardiac radiopharmaceutical and echocardiographic
contrast agents; and five investigational new
drug (IND) filings and first-in-man evaluations.
His experience also includes extensive
interactions with regulatory authorities in the
U.S., Europe, and Canada regarding product
development and labeling issues. Peter was
responsible for obtaining the first Written
Request for pediatric studies from the FDA’s
Medical Imaging Division.
Education
Peter received his medical degree from Leeds
University and trained in internal medicine
and cardiology prior to joining the pharmaceutical industry. Peter is a member of the
Royal College of Physicians and a Fellow of
the Faculty of Pharmaceutical Medicine. He
has also served as a board member of the
Medical Imaging Contrast Agent Association
(MICAA), a nonprofit association composed of
manufacturers and developers of contrast
agents used in the fields of medicine and life
sciences. He has acted in various capacities for
MICAA, including two terms as board chairman.
Development Area:
MEDICAL IMAGING
Lead Therapeutic Area(s):
CARDIOVASCULAR
Geographic Responsibility:
GLOBAL
Henri Francois Cuénoud, M.D.
Scientific Advisor
For over ten years, Henri Francois has
independently reviewed imaging data on 14
studies with PAREXEL. Additionally, he has
served as medical owner with PAREXEL,
advised on the development of data validation
specifications of cardiology specific medical
outlier reports, provides protocol and submission
consultation to sponsors, and advises on
software developments and innovations to
better support cardiology trials.
Henri Francois is an associate professor of
medicine in the areas of cardiovascular medicine
and non-invasive cardiology at the University
of Massachusetts Medical School (UMMS) and
the UMass Memorial Medical Center, in
Worcester, Massachusetts, where he also holds
the position of non-invasive cardiologist with
specialty in echocardiography. In addition, Henri
Francois is an associate professor of pathology
and director of the Cardiovascular Pathology
Laboratory. Henri Francois has an important
teaching position at the University of
Massachusetts Medical School where he is
director of the Cardiovascular Pathology Course,
co-director of the Cardiovascular Pathophysiology Course, co-director of the Biology of Disease
Course (second-year medical school), director of
Cardiovascular System Course (first-year
medical school), and co-director of the Organ
System Diseases Course (first and second-year
medical school).
Work Experience
Under a five-year Clinician-Scientist Award from
the American Heart Association, Henri Francois
concentrated his research interests in the
areas of: the pathogenesis of atherosclerosis;
atherosclerosis inhibition; myocardial
pathology; and the pathophysiology of arterial
spasm, coronary thrombosis, and atherosclerotic
plaque rupture. He is the author of several
published articles and has received numerous
professional awards for his efforts in both
research and teaching, including basic science
and clinical “Outstanding Teacher Awards” every
year since 2001 from medical studentsat UMMS.
Education
A native of Switzerland, Henri Francois received
his medical degree from the University of Geneva
Medical School, and completed his residency at
the Geneva University Hospital. From there, he
moved to the United States to complete a
fellowship in Cardiovascular Medicine UMMS.
Development Area:
MEDICAL IMAGING
Lead Therapeutic Area(s):
CARDIOVASCULAR (SAFETY & EFFICACY)
ONCOLOGY
MUSCULOSKELETAL
Geographic Responsibility:
NORTH AMERICA
Richard Jacobs, M.D., M.H.A.
Senior Vice President, Medical Affairs
An esteemed radiologist, Richard is PAREXEL’s
Senior Vice President of Medical Affairs where
he has been a leader of PAREXEL Informatics’
medical imaging management team for more
than 16 years. He is PAREXEL Informatics’
most experienced medical leader for worldwide
clinical trials. He has advised many of the world’s
largest pharmaceutical, biotechnology and
medical device companies on the use of imaging
to determine the effectiveness and safety of
their products. He established the PAREXEL
Medical Group; now more than 30 full-time medical experts including specialists in radiology,
neuroradiology, nuclear medicine, oncology,
and cardiology, bone metabolism, magnetic
resonance (MR) physics and arthritis located
in Boston, Berlin and Hyderabad. He also
established the company’s panel of more than
30 Scientific Advisors, many of who are world
renowned, and 330 active physician consultants
in radiology, oncology and cardiology. Richard
has established multiple dedicated PAREXELimaging reading sites in the US, the EU and in
India. He has chaired or lectured throughout the
United States, Europe and Asia at conferences on
the impact of medical imaging in clinical trials.
Work Experience
Prior to joining PAREXEL, Richard served as
chairman of the Department of Radiology and
Diagnostic Imaging at Memorial Health Care
for six years. Following the merger with UMass,
Richard was vice-chair of the Department of
Radiology at UMass Memorial Health Care.
Education
Richard received his medical degree from the
University of Massachusetts Medical School.
He completed his radiology residency at the Mt.
Auburn Hospital in Cambridge and a fellowship
at the Deaconess Medical Center.
Development Area:
MEDICAL IMAGING
Lead Therapeutic Area(s):
CARDIOVASCULAR
ONCOLOGY
Geographic Responsibility:
GLOBAL
Edwin Palmer, M.D.
Scientific Advisor
Edwin has been a scientific advisor for PAREXEL
Informatics since 2009. He supports PAREXEL
in the software development area for nuclear
medicine. He is a key PAREXEL reviewer
and adjudicator in many prostate cancer trials.
He is also experienced in single-photon
emission computed tomography (SPECT)
imaging on novel imaging tracers in the greater
oncology space. He frequently advises sponsors
on review flow and patient status determinations for prostate cancer trials.
Work Experience
Edwin has over 30 years of extensive radiology
experience with a strong emphasis on
nuclear medicine and cardiovascular imaging.
Currently Edwin serves as an Associate
Radiologist and Director of Clinical Nuclear
Medicine/PET (positron emission tomography)
at Massachusetts General Hospital in Boston.
Previously, Edwin served as an Assistant
Radiologist and an Assistant in Radiology at
Massachusetts General Hospital.
After his residency, Edwin channeled his
passion for radiology, nuclear medicine and
education into teaching. He has instructed
numerous radiology courses at Harvard
Medical School and has been instrumental
in both developing and teaching radiological
courses at Massachusetts General Hospital.
Courses that Edwin has instructed cover a
range of topics such as basic nuclear medicine, cardiovascular nuclear medicine and the
science of radiological imaging, among others.
Today Edwin continues to serve as an Instructor
in Radiology at Harvard Medical School.
Edwin is licensed with the Massachusetts
Board of Registration in Medicine. He is also
certified with the American Board of
Radiology and American Board of Nuclear
Medicine. Edwin maintains memberships
with the American College of Radiology,
Massachusetts Radiological Society,
Radiological Society of North America and
the Society of Nuclear Medicine.
As an avid supporter of education and
advancing the field of radiology, Edwin has
authored numerous reports across a range
of topics including, radionuclide imaging,
ventilation perfusion scans and PET
imaging. Conditions covered in these reports
include lymphoma, pulmonary embolus,
glioma,osteomyelitis and septic arthritis.
Edwin also authored the book, Practical
Nuclear Medicine, which was published by
W.B. Saunders in 1992. At Massachusetts
General Hospital he serves in a number
of leadership roles such as the Nuclear
Radiology Fellowship Director and Director
Education within the Nuclear Medicine and
Molecular Imaging Division. Edwin also sits
on the Radiology Resident Selection and
Education Committees.
Education
Edwin earned his M.D. from Tufts University
School of Medicine in 1978 and immediately
after, served as an intern at Boston City
Hospital. Subsequently, he completed his
postdoctoral training in the Department
of Radiology at Massachusetts General
Hospital—first performing his residency and
then a Clinical Fellowship in Nuclear Medicine.
Development Area:
MEDICAL IMAGING
Lead Therapeutic Area(s):
CARDIOVASCULAR
ONCOLOGY
Geographic Responsibility:
NORTH AMERICA
Peggy Harrigan
Medical Research Scientist
Peggy joined PAREXEL in 2012 and in her role
as a Medical Research Scientist, she sup­ports
cardiovascular and oncology trials with cardiac
safety components, leveraging her 21 years
spent as a cardiac sonographer. She is highly
proficient in cardiac and vascular examinations
(carotid, arterial and venous lower extremity,
and aortic ultrasounds). Additionally she
provides compliance training to the imaging
study team on FDA and Good Clinical Practice
regulations. Peggy supports cardiac sonographers at investigator sites by providing detailed
seminars on imaging guidelines and required
imaging parameters that ensure consistent,
accurate, and high quality study data. She has
provided reviewer trainings and support for
many cardiac safety and efficacy trials and in
doing so has established a close relationship
with cardiovascular reviewers. When necessary,
her cardiovascular background branches into
trials with more expanded modality needs, such
as coronary angiography, cardiac MR and other
vascular ap­plications.
Work Experience
Peggy has experience working with patients,
physicians, and experienced sonographers
across a range of cardiac imaging including
situations such as scans immediately after
major cardiac surgery, trauma, life support,
CODE, and stroke. This included following
patients with a wide range of cardiac
pathology, as well as surgical patients with
coronary bypass, stent, varied medical devices,
including left ventricular assist device (LVAD) ,
and shunt closure devices, and transplants.
Additionally, she has supported academic
research publications by culling cardiology
images and has trained students at various
labs to introduce lab-specific cardiac
ultrasound protocols.
Education
In 1998, Peggy received a Certificate in
Cardiovascular Ultrasound from the Ultrasound
Diagnostic School in New York. She continued
her ultrasound training in 2000 at the
Thomas Jefferson Medical School, Philadelphia,
Pennsylvania. She has been listed on the
Cardiovascular Ultrasound Registry since 2009.
WHEREVER YOUR
JOURNEY TAKES YOU,
WE’RE CLOSE BY.
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